• Journal of Microbiology and Biotechnology
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• v.13 no.3
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• pp.338-343
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• 2003

Various factors, such as the adsorption pH, adjuvant dose, and adjuvant age, which affect the adsorption degree and immunogenicity of an antigen, were investigated. In addition, the effect of pH, antigen content, and adjuvant content on immunogenicity was also studied through animal experiments. Within the ranges studied, a low pH for adsorption, freshly preformed gel, and low pH formulation for the combined DTwP-HepB vaccine were preferrable for the adsorption of the antigens. In addition, a higher DT content was found to have a positive effect on the HBsAg immunogenicity in the combined vaccine. Accordingly, considering the factors affecting the adsorption rate and immunogenicity of the antigens, a novel DTwP-HepB vaccine (40 Lf/ml of diphtheria toxoid, 15 Lf/ml of tetanus toxoid, 20 OU/ml of detoxified whole cell pertussis, $24\;\mu\textrm{g}$ of HBsAg, $24\;\mu\textrm{g}\;Al/ml\;of \;Al(OH)_3\;gel,\;776\;\mu\textrm{g}\; Al/ml\;of\;AIPO_4\;gel$, and pH 7.1) was developed, whose immunogenicity was comparable to the case of administrating, separately and simultaneously, a combined DTwP vaccine (40 Lf/ml of diphtheria toxoid, 15 Lf/ml of tetanus toxoid, 20 OU/ml of detoxified whole cell pertussis, $300\;\mu\textrm{g}\;Al/ml\;of\; AIPO_4\;gel$, and pH 7.1) and mono HepB vaccine [$Hepavax^{\circledR},\;24\;\mu\textrm{g}/ml$ of HBsAg and $500\;\mu\textrm{g}\;Al/ml\;of\;Al(OH)_3\;gel$], which satisfies the potency criteria of the K-FDA for a combined DTwP vaccine and mono HepB vaccine.

• Clinical and Experimental Pediatrics
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• v.64 no.12
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• pp.602-607
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• 2021

In April 2020, the Ministry of Food and Drug Safety licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugated to tetanus protein, and hepatitis B (HepB) (recombinant DNA) vaccine, DTaP-IPV-Hib-HepB (Hexaxim, Sanofi Pasteur), for use as a 3-dose primary series in infants aged 2, 4, and 6 months. The DTaP-IPV-Hib-HepB vaccine is highly immunogenic and safe and provides a long-term immune response based on studies performed in a variety of settings in many countries, including Korea. This report summarizes the Committee on Infectious Diseases of the Korean Pediatric Society guidelines for the use of this newly introduced hexavalent combination vaccine.

• Clinical and Experimental Vaccine Research
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• v.12 no.3
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• pp.232-239
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• 2023

Purpose: The purpose of this study was to compare the antigenic potency and stability of tetanus and diphtheria (Td) vaccines when combined with aluminum phosphate (AlPO₄) and liposome adjuvants. Materials and Methods: In vitro and in vivo analyses were conducted using the single radial immunodiffusion method and sodium dodecyl sulfate-polyacrylamide gel electrophoresis. The Td vaccines were prepared with AlPO₄ adsorption and liposome-mediated delivery, and protein antigens were characterized using these methods. Results: The results revealed that the liposome-mediated Td vaccines exhibited higher immunogenicity compared to the AlPO₄-adsorbed Td vaccines. Additionally, the liposome-mediated Td vaccines demonstrated higher stability as native antigens. Conclusion: This study highlights the importance of utilizing liposome adjuvants in vaccine development. The liposome-mediated Td vaccines showed enhanced immunogenicity and stability, making them a promising approach for improving vaccine efficacy. Understanding and optimizing adjuvant strategies can contribute to the development of effective vaccines against various diseases.

• Journal of Microbiology and Biotechnology
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• v.12 no.5
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• pp.787-792
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• 2002

When developing a combined DTaP-HepB vaccine, toxicity and HBsAg immunogenicity are both important considerations. Thus, for a combined DTaP-HepB vaccine with a low toxicity, the effect of the DTaP content and $Al(OH)_3$, gel concentration on the vaccine toxicity was investigated. Within the range studied, the higher the concentrations, the higher the vaccine toxicity. The importance of the tetanus toxoid content in the combined DTaP-HepB vaccine was also revealed. A higher concentration of the tetanus toxoid was found to have a negative effect on the stability of the HBsAg immunogenicity in the combined vaccine. Accordingly, considering the factors affecting toxicity and HBsAg immunogenicity, a novel DTaP-HepB vaccine (30 Lf/ml of diphtheria toxoid, 5 Lf/ml of tetanus toxoid, 10 $\mu\textrm{g}$ PN/ml of acellular pertussis, 24 $\mu\textrm{g}$/ml of HBsAg, and 500 $\mu\textrm{g}$ Al/ml of $Al(OH)_3$ gel) was developed. It has a low toxicity and a stable HBsAg immunogenicity and also satisfies the potency criteria of K-FDA for a combined DTaP vaccine.

• Pediatric Infection and Vaccine
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• v.25 no.3
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• pp.141-147
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• 2018

Purpose: Despite effectiveness and safety of maternal tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination, Tdap vaccination coverage during pregnancy remains quite low. We assessed the knowledge, attitude and practice on maternal Tdap vaccination among pregnant women. Methods: This study was a cross-sectional survey of pregnant women who visited tertiary obstetrics and gynecologic units in Seoul and Gyeonggi province of Korea. Individual questionnaires were administered to assess knowledge, attitude and practice on maternal immunization with Tdap. Results: The questionnaires were completed by 184 pregnant women; 158 (86%) had not received information from doctors about pertussis and Tdap, and 166 (90%) did not know the need for Tdap vaccination. Only 7% of pregnant women unlikely to receive Tdap vaccine during current pregnancy answered 3 or more of the 5 knowledge-based questions correctly. By logistic regression analysis, recommendation by doctor (adjusted odd ratio [OR], 236.2; 95% confidence interval [CI], 12.6-4,432), belief that the vaccine is effective (adjusted OR, 40.21; 95% CI, 2.35-687.7), and belief that the vaccine is safe (adjusted OR, 19.83; 95% CI, 1.54-255.9) were significantly important factors to respondents' intention to be vaccinated. Conclusions: Most pregnant women seem to be neither recommended nor adequately informed about Tdap vaccination. Information given by health care professionals is very important to increase Tdap coverage among pregnant women.

• Clinical and Experimental Pediatrics
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• v.50 no.4
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• pp.355-362
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• 2007

Purpose : We conducted the study to evaluate the immunogenicity and safety of three component DTaP vaccine ($Infanrix^{(R)}$) in a group of Korean healthy infants on a three-dose primary vaccination. And we compared the immunogenicity of this DTaP vaccine with two component DTaP vaccine which has been widely used in Korea. Methods : We enrolled one hundred fifty one healthy infants aged 8-9 weeks. These infants were vaccinated at age 2, 4 and 6 months of age with three component DTaP vaccine. Solicited adverse events were actively monitored for 72 hours following each vaccination, and all adverse events after each vaccination were observed for three weeks. Anti-diphtheria toxoid Ab., anti-tetanus toxoid Ab., anti-pertussis toxin Ab., anti-filamentous hemagglutinin Ab., and anti-pertactin Ab. were measured using ELISA for assessing immunogenicity of study vaccine in 60 infants. Immunogenicity analysis of two component DTaP vaccine was performed with same methods in 14 infants as control. Results : The seroconversion rates of anti-diphtheria toxoid Ab, anti-tetanus toxoid Ab. anti-filamentous hemagglutinin Ab. were 100% in both group. Seroconversion rate of anti-pertactin Ab in study group was 100%, but the rate in control group was 50%. However, geometric mean concentration of anti-pertussis toxin Ab. was higher in control group. Mild local and systemic reactions were observed within three days after vaccination, and no serious adverse events related study vaccine were happened during study period. Conclusion : Our study results suggest that three component DTaP vaccine ($Infanrix^{(R)}$) is a well-tolerable and high immunogenic vaccine, especially anti-Pertactin Ab. of the study vaccine is very immunogenic. It can be available as routine DTaP vaccination in our infants.

• Clinical and Experimental Pediatrics
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• v.51 no.11
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• pp.1185-1190
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• 2008

Purpose : This study was undertaken to evaluate the immunogenicity and reactogenicity of Td booster immunization in early preadolescents of Korea. Methods : Healthy preadolescents, who had been vaccinated with 4 or 5 doses of DTaP vaccines until 6 years old age, were enrolled in this study from August 2006 to April 2007. Diphtheria and tetanus anti-toxoid antibodies in sera were measured by ELISA just before vaccination and 4 weeks after vaccination to evaluate immunogenicity. Local and systemic adverse reactions observed for 4 weeks after vaccination to access reactogenicity. Results : 183 preadolescents were enrolled and mean age was $11.40{\pm}0.51$ years old. All subjects achieved seroprotective diphtheria and tetanus anti-toxoid antibodies (titers ${\geq}0.1IU/mL$) after Td booster vaccination. Among 183 vaccinees, 73.8% showed local adverse reactions and 37.2% systemic adverse reactions. Pain at injection site (66.1%) was the most common local reaction, and the most commonly shown systemic reaction was myalgia (17.5%). The adverse reactions were spontaneously relieved within three days after vaccination. Conclusion : Td vaccine in this study was high immunogenic and showed an acceptable tolerance in Korean preadolescents. Td booster vaccination at 11-12 years old is the most effective method to increase compliance of the vaccination and to decrease the incidence of diphtheria and tetanus.

• Clinical and Experimental Pediatrics
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• v.62 no.7
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• pp.252-256
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• 2019

The Committee on Infectious Diseases of the Korean Pediatric Society recommended immunization schedule for children and adolescents aged 18 years or younger in the 9th (2018) edition of Immunization guideline. This report provides the revised recommendations made by the committee and summarizes several changes from the 2015 guideline. National immunization program (NIP) launched a human papillomavirus (HPV) immunization for girls aged 12 years in 2016. NIP has also expanded age indication for inactivated influenza vaccine (IIV) to 12 years of age in the 2018-2019 season. Quadrivalent IIVs with a full dose (0.5 mL) are approved for all children of 6 months or older. Recommendations of live attenuated influenza vaccine were removed. For inactivated Japanese encephalitis vaccine, first 2 doses are considered as the primary series. Recommendations for use of newly introduced vaccines (diphtheria-tetanus-acellular pertussis/inactivated poliovirus/Haemophilus influenzae type b, 9-valent HPV, new varicella vaccine, new quadrivalent IIV, and attenuated oral typhoid vaccine) were added. Lastly, monitoring system for adverse events following immunization was updated. Other changes can be found in the 9th edition of Immunization guideline in detail.

• Pediatric Infection and Vaccine
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• v.17 no.2
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• pp.156-168
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• 2010

Purpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, $Infanrix^{TM}$ IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-ose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were ${\geq}99.5%$ and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.

• Korean Journal of Clinical Pharmacy
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• v.21 no.3
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• pp.280-291
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• 2011

Vaccines are products for immunization which can provoke antibodies by eliciting immune reponses without causing disease and have played an important role in preventing fatal and contagious diseases as well as H1N1 influenza. They are classified by two following categories; lived attenuated vaccine and killed vaccine and currently commonly using vaccines are BCG, diphtheria, tetanus, mumps, measles, rubella, polio, Haemophilus influenza type b, hepatitis B, influenza etc. All vaccines must be used correctly to reach optimal therapeutic goals and also informed well to patients to decrease potential problems. In order to do, pharmacists must have good knowledge of vaccines. The purpose of this study is to evaluate the necessity of vaccine education for pharmacists and develop a vaccine leaflet for patient counseling. We have performed a survey with questionnaire for a total of 176 pharmacists and nurses(hospital pharmacists, n=65; community pharmacists, n=50; hospital nurses, n=61) from January 27th to March 12th, 2010. The questionnaire includes items about vaccine education and counseling and 12 quizzes to evaluate responders' knowledge of vaccines. We used the SPSS(Version 12. for windows) program to analyze the data. In results, 94.9% of all responders said they had not been educated on vaccines. And only 1.1% of all responders said they know about vaccines enough to counsel patients. Pharmacists who have an experience recommending vaccines to other people are 21.7%. On the other hand, nurses who have an experience recommending vaccines to other people are 55.7%(p=0.000). The mean number of correct answers at the 12 quizzes are followings; hospital pharmacist, 8.1; community pharmacist, 6.1, hospital nurses, 6.2(p=0.000). A vaccine leaflet for patient counseling is developed with several references. In conclusion, due to no opportunity of vaccine education, pharmacists have no confidence to counsel patients and lack of knowledge of vaccine. But importance of vaccine's role is increasing, pharmacists should counsel patients in vaccination. So they need vaccine education and a vaccine leaflet will be helpful for their counseling.